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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

Clinical trials, studies, data, and updates reported in Medical Device News Magazine.

Auxilius Pharma Announces Top-line Results of its First-in-Human Clinical Study into the Pharmacokinetics, Safety and Tolerability of Antianginal AUX-001

AUX-001 is an innovative, once-daily, extended-release formulation of Nicorandil. For decades, immediate-release, twice daily Nicorandil has been a cornerstone treatment for chronic angina symptoms outside the US, distinguished by its dual mechanism of action that targets both the micro- and macrovascular coronary artery flow bed, and providing sustained angina symptom relief without the common issue of tachyphylaxis seen with other anti-anginal vasodilators like long-acting nitrates. AUX-001 offers efficacy comparable to conventional anti-anginal medications such as beta-blockers, calcium channel blockers, and long-acting nitrates while also potentially enhancing control of the underlying coronary disease and reducing angina related hospitalizations.

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Bodyport Reports | Heart Failure Monitoring Technology Doubles Sensitivity for Predicting Events While Minimizing False Alerts Versus Standard of Care

“This should be welcome news for patient care teams because a greater prediction rate with fewer false alerts translates into more effective and efficient care,” said Corey Centen, founder, president, and chief technical officer at Bodyport. “What’s more, use of the Cardiac Scale and the Congestion Index is a seamless transition for clinicians and patients because it enhances, rather than replaces, the existing pathways built around weight monitoring. The lower alert rate should lead to workflow efficiencies because care teams—who are often feeling overly burdened by the large number of notifications and data flowing in—will spend less time responding to false alerts.”

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Peripheral Arterial Disease

BD Initiates International Study to Expand Treatment Options for Patients with Peripheral Arterial Disease

Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic and National Principal Investigator of the AGILITY Study said, “When we’re addressing advanced peripheral arterial disease, a self-expanding covered stent can play an important role. We need a stent that can track to the lesion, apposes the vessel wall and ultimately provides long-term durability. We’re excited to see how this technology performs.” 

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